A new lawsuit accuses Johnson & Johnson and Procter & Gamble of having deceived consumers about decongestant cold medicines containing an ingredient that a unanimous U.S. Food and Drug Administration advisory panel this week declared ineffective.
According to a proposed class action filed on Wednesday in Pensacola, Florida, federal court, the companies knew or should have known by 2018 that their marketing claims about products containing phenylephrine were false and misleading.
That year was when new FDA guidance for evaluating symptoms related to nasal congestion demonstrated that earlier data about phenylephrine’s effectiveness could no longer be relied upon, the complaint said.
The plaintiff, Steve Audelo, said he bought Johnson & Johnson’s Sudafed PE and Benadryl Allergy Plus Congestion, and Procter & Gamble’s Vicks NyQuil, based on the companies’ “false and deceptive” claims that the products worked.
Audelo, a Florida resident, said the claims violated that state’s consumer protection laws. He is seeking at least $5 million in damages for people who bought the products in the United States in the last five years.
Benadryl and Sudafed are made by Johnson & Johnson’s former consumer healthcare business, which was named as a defendant.
The business was spun off in a May 3 initial public offering and is now known as Kenvue.
Johnson & Johnson, Kenvue and Procter & Gamble did not immediately respond on Thursday to requests for comment.
The FDA panel reviewed several studies before concluding that phenylephrine was essentially no better than a placebo.
According to an agency presentation, about 242 million products with phenylephrine were sold in the United States last year, generating $1.76 billion of sales and accounting for about four-fifths of the market for oral decongestants.
Another decongestant, pseudoephedrine, is considered safe, but has been moved behind pharmacy counters because people can process it illegally into methamphetamine. Sales of oral products that contain it totaled $542 million last year.
The FDA generally follows but does not always adopt its advisory panels’ recommendations.
On Thursday, the agency said it would seek public comment on whether products with phenylephrine should be pulled from store shelves.
The case is Audelo v Johnson & Johnson Consumer Inc et al, U.S. District Court, Northern District of Florida, No. 23-24250.
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